Senior Scientist, Analytical Science & Technology

Aurion Biotech, Inc.; Cambridge, Northern (MA, KY); On-site; USD 140,000 - 155,000; Full time

Job summary

Aurion Biotech, Inc. in Cambridge, MA is seeking a Senior Scientist, Analytical Science & Technology to lead method transfers and validations at external CDMOs.

You will author and review protocols, evaluate data, and ensure regulatory compliance for QC testing of cell therapy products. The role requires strong experience with cGMP, USP methods, and collaboration across QC, Analytical Development, CMC, and QA teams to drive successful transfer projects and validate analytical approaches in

Qualifications

• 5+ years in Quality Control or related function, with advanced degree.
• Experience with method validations and USP method verification in late-stage development.
• Hands-on knowledge of cGMP, pharmacopeial and regulatory guidelines.

Responsibilities

• Lead method transfers and validations at external CDMOs.
• Review analytical results and support deviations and investigations.
• Develop and implement monitoring tools for assay validity and data trends.
• Collaborate with CDMOs, Analytical Development, CMC and QA to ensure QC compliance.

Skills

Quality Control

Flow Cytometry

Regulatory compliance

Data analysis

Cross-functional collaboration

Education

Master's Degree

PhD

Bachelor's Degree

Tools

JMP

MS Office

Job description

Description

JOB TITLE: Senior Scientist, Analytical Science & Technology

LOCATION: Cambridge, MA (hybrid-remote)

REPORTS TO: Senior Manager, Analytical Science & Technology

SALARY RANGE: $140,000 to $155,000

ABOUT THE POSITION

This position is a unique and exciting opportunity to join a growing team of passionate professionals at the forefront of cell therapy innovation in ophthalmology. As a Senior Scientist, AS&T you will play a critical role in accomplishing our mission. The Sr. Scientist, AS&T is primarily responsible for leading all method transfers and validations at our external CDMO. This includes authoring and reviewing protocols, reviewing raw data and authoring reports. Additional responsibilities include independently investigating and troubleshooting methods as challenges arise, reference standard qualification, and stability compliance.

KEY RESPONSIBILITIES

• Support QC deliverables for cellular drug substance and drug product development in late-stage clinical development
• Review of outsourced GMP work and serve as Lead SME for method validations, assay control establishment, and method bridging/USP equivalency testing.
• Build tools to monitor assay validity and maintain them. Periodically assess assay validity and investigate as needed
• Interface with and build strong collaborative relationships with external stakeholders (CMOs or contract labs) and internal stakeholders including Analytical Development, CMC, and Quality Assurance
• Independently resolve technical issues; effectively collaborate with internal and external teams to solve issues with broad scope and/or high complexity
• Escalate challenges to management; develop constructive technical proposals and implement solutions for resolution of challenges
• Ensure compliance within QC by monitoring test methods, SOPs, and QC analytical data to cGMPs, pharmacopeial, and regulatory requirements
• Provide technical support for deviations, laboratory investigations, and evaluate proposed analytical change requests
• Authoring and reviewing protocols, reviewing raw data and authoring reports
• Maintain flexibility as is phase appropriate
• Other duties as assigned

ABOUT AURION BIOTECH

With offices in Seattle, Boston, and Tokyo, Aurion Biotech is a clinical-stage biotech company, whose mission is to restore vision to millions of patients with life-changing regenerative therapies. The Company’s first candidate is for the treatment of corneal edema secondary to endothelial dysfunction, and one of the first clinically validated cell therapies for corneal care; it was recently granted regulatory approval from Japan’s PMDA. Aurion Biotech is the recipient of the prestigious Prix Galien award for best start-up in biotech. The Company is preparing for clinical trials in the U.S. We are growing rapidly and seek to hire highly motivated candidates from diverse backgrounds, cultures, and experiences, who share our values:

• Stewardship: We make the world a better place for our patients, our communities, our clinicians, and our colleagues. We act responsibly as individuals, as employees, and as a company.
• Transformation: We embrace our challenges, our successes, and our failures. We are curious, we take risks, and we collaborate.
• Grit: We break down walls and strive to achieve the impossible. We are persistent and resilient, and we deliver on our commitments.

Aurion Biotech has a lot to accomplish in the next few years, and this role is key to our success. Privately held, Aurion Biotech is backed by Alcon, the global leader in eye care. To learn more about Aurion Biotech, visit www.aurionbiotech.com.

LIFE AT AURION BIOTECH

We want our people to wake up every morning excited and energized for work. We value employees, which is why we invest in making life at Aurion Biotech healthy, fun, and rewarding:

• Robust Benefits: We offer full health insurance to employees and their families, and all the acronyms: 401(k) matching, EAP, FSA, and generous PTO.
• Total Rewards: We offer competitive compensation packages to ensure all Aurion employees are rewarded for their hard work.
• Perks and Fun: Paid parking, subsidized commuter passes, in-office catered lunches, team events, and community projects are just a few ways that we bond, celebrate each other, have fun, and live our values.

Requirements

QUALIFICATIONS AND EDUCATION

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• 5+ years of experience in Quality Control or other related function with a Master's Degree (or a PhD with 2 years of relative QC experience).
• Or 8+ years of experience in Quality Control or other related function with a Bachelor's Degree
• Experience with method validations and USP method verification in late-stage clinical development
• Excellent working knowledge of cGMP requirements, pharmacopeial and relevant guidelines (EMA, FDA, ICH) as they relate to QC testing for cell therapy and method validations
• Experience reviewing analytical test results and solving technical problems associated with a wide variety of cell-based QC assays
• Must have hands-on experience with and a deep understanding of Flow Cytometry
• Experience charting data and identifying trends observed during studies. Working experience with statistical analysis software (JMP highly preferred) is required
• Ability to identify risks associated with method qualifications and validations with a proven track record of resolving challenges as they arise
• Demonstrated expertise in analytical method lifecycle management including test method approval, method verification, method validation, and method transfer

REQUIRED SKILLS, KNOWLEDGE, AND ABILITIES

• Proven ability to interface with CDMOs
• Able to rapidly adapt to changing environment and circumstances requiring flexibility, tolerance and great sense of urgency while ensuring that all cGMP and Regulatory requirements are met
• Strong collaboration and demonstrated ability to work cross-functionally at all levels of the organization to drive strong business partner relationships
• Demonstrated proficiency with managing assigned project deliverables to ensure team success
• Strong written and verbal communication skills with ability to summarize scientific data in a logical, organized, clear and persuasive manner
• Quality mindset with demonstrated ability to address compliance gaps
• Advanced proficiency in use of MS Office products
• Ability to work effectively both independently and with other team members